Active Ingredient(S)
Phenylephrine HCl 5mg
Decongestant Pe Tablet
FDA Label NDC 69168-271
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Decongestant Pe (NDC 69168-271). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, ask a doctor before use if, when using this product, stop use and ask a doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal decongestant
Use(S)
- temporarily relieves sinus congestion and
pressure - temporarily relieves nasal congestion due to the
common cold, hay fever or other upper respiratory
allergies
Warnings
you are now taking a prescription monoamine
oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric or emotional conditions, or
Parkinson's disease), or for 2 weeks after stopping the
MAOI drug. If you do not know if your prescription drug
contains an MAOI, ask a doctor or pharmacist before
taking this product.
Ask A Doctor Before Use If
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
When Using This Product
do not exceed recommended dose
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
Pregnancy/Breastfeeding
ask a health professional before use
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Adults and children 12 years and over: 1 tablet every 4 hours
- do not take more than 6 tablets in 24 hours
Children under 12 years ask a doctor
Other Information
- do not use if imprinted safety seal under cap is broken or missing
Storage
- store at room temperature 20°– 25°C (68°– 77°F)
Inactive Ingredients
croscarmellose sodium, lactose, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake,
hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide.
May contain propylene glycol
Questions
Call 1-888-952-0050 Monday through Friday
Principal Display Panel
Decongestant 5mg (271 Phenylephrine HCl 5mg 1)
* Please review the disclaimer below.
